Class 4 drug alert – Caution in use – Packs containing incorrect PIL

A Class 4 drug alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for Zoledronic acid solution for infusion 5mg.

DRUG ALERT

Class 4 drug alert – Caution in use – Packs containing incorrect patient information leaflet

Ref:  EL (19)A/08

Date: 04 April 2019

 Zoledronic acid solution for infusion 5mg

(Manufactured by Sun Pharmaceutical Industries Europe BV)

PL 31750/0054

A Class 4 drug alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for Zoledronic acid solution for infusion 5mg.

Description of alert:

Ranbaxy UK Ltd (a Sun Pharmaceutical Company) has informed the MHRA that certain packs from the batch above mistakenly contain the wrong patient information leaflet (PIL).

Advice to healthcare professionals:

Pharmacy teams should check the PIL inside packs of the affected batch before dispensing. If the pack contains the wrong leaflet, this should be removed and a copy of the correct PIL should be provided. This can be downloaded from the electronic medicines compendium website.

Further information can be found on the MHRA section on the GOV.UK website.

Produced by the NPA Pharmacy Services team April 2019.